Search Results

VENTRALIGHT™ ST Mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.

The ECHO 2™ Positioning System is intended to facilitate the delivery and positioning of soft tissue prostheses during laparoscopic hernia repair.

The Subject Device, VENTRALIGHT™ ST Mesh with ECHO 2TM Positioning System is provided sterile for single use and consists of an implantable surgical mesh (VENTRALIGHT™ ST Mesh) with a pre-attached mesh positioning system (ECHO 2™ Positioning System). The Subject Device is designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia repair.

The provided text describes the regulatory clearance for a medical device, the VENTRALIGHT™ ST Mesh with ECHO 2™ Positioning System, and its substantial equivalence to a predicate device. However, it does not detail specific acceptance criteria and the comprehensive study results in the format requested for an AI/algorithm-based device.

This document pertains to a surgical mesh and a positioning system, which are physical medical devices, not an AI or algorithm-based system. Therefore, many of the requested sections related to AI/algorithm performance metrics (like sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of device and are not present in the provided text.

Based on the provided information, here's what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

The document states that "All samples tested met the established acceptance criteria" for product testing and cadaveric studies, and "The VENTRALIGHT™ ST Mesh with ECHO 2™ Positioning System passed all the test requirements and demonstrated substantial equivalence to the test results of the Predicate Device." However, the specific numerical acceptance criteria or the raw performance data are not provided in this summary. The general categories of testing and the conclusion of meeting criteria are mentioned.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Sample Size for Test Set: The document states "All samples tested met the established acceptance criteria" for product testing and cadaveric studies, but it does not specify the numerical sample sizes used for these tests.
• Data Provenance: Not specified.
• Retrospective/Prospective: Not specified, although cadaveric studies would inherently be prospective in their execution given the study design.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not applicable as this isn't an AI/algorithm device requiring expert ground truth for classification. The "ground truth" for this physical device is based on objective measurements and observations during mechanical and cadaveric testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. Clinical studies were not performed, and this is not an AI-assisted device for human interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For biocompatibility, the ground truth is established by adherence to ISO 10993-1 standards and successful performance in standardized biological tests. For product testing (mechanical and simulated use) and cadaveric studies, the "ground truth" or acceptance criteria are based on pre-defined engineering specifications, functional requirements, and safety/feasibility observations relative to the predicate device.

8. The sample size for the training set:

Not applicable. There is no AI/algorithm training set for this physical device.

9. How the ground truth for the training set was established:

Not applicable.

Ask a specific question about this device